Easy@Home Blood Pressure Monitor

GUDID 00850253007185

EASY HEALTHCARE CORPORATION

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00850253007185
• NIH Device Record Key: d10da2cf-9683-450a-9b7c-9b894a82f9ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Blood Pressure Monitor
• Version Model Number: EBP-095
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850253007185 [Primary]
GS1	10850253007182 [Package]; Package: [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101681

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-08-01

On-Brand Devices [Easy@Home Blood Pressure Monitor ]

• 00850253007185: EBP-095
• 00850003180090: EBP-095
• 00810038630175: EBP-095
• 10810038630028: EBP-020
• 10810038636266: EBP-095 Black